Executive Director, API Development, Small Molecule (API Development)

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings and events is expected, approximately 25%.

Salary: $247,000–$337,000 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Set the long-term vision, strategy, and operating model for API Development within the small-molecule pipeline.
• Lead API process development, technology transfer, process validation, manufacturing readiness, and lifecycle management.
• Direct process, instrument, and equipment design and scale-up from laboratory through pilot and manufacturing operations.
• Advise Technical Operations leadership on portfolio decisions, resources, risks, investments, and development strategy.
• Partner with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations, Commercial teams, vendors, CROs, CMOs, and regulatory bodies.
• Build organizational capabilities through coaching, succession planning, leadership development, metrics, and continuous improvement.

Requirements

• PhD with 10+ years of CMC experience, MS with 12+ years, or BS with 15+ years in the pharmaceutical industry.
• Extensive expertise in route design, small-molecule API process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readiness.
• Strong experimental skills and the ability to independently solve complex development problems.
• Thorough knowledge of cGxP, CMC, ICH, and USP/EP/JP requirements.
• Experience authoring, reviewing, and approving CMC sections of INDs, NDAs/MAAs, and other regulatory submissions.
• Experience managing multiple programs, resources, staff, CROs, and CMOs from discovery through commercialization.

Nice to have

• Experience with compounds used for inhalation and combination products.

Culture & Benefits

• Patient-focused culture emphasizing curiosity, inclusion, meaningful progress, and continuous improvement.
• Medical, dental, vision, mental health, wellbeing reimbursement, and Employee Assistance Program support.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, networking, employee resource groups, service programs, and recognition opportunities.